Study Comparing the Safety and Efficacy of BMS-224818 to Cyclosporine, in Patients Receiving a Kidney Transplant, When Used in Combination With CellCept, Simulect, and Corticosteroids. - Tabular View

Tracking Information
First Received Date ^ICMJE	May 3, 2002
Last Updated Date	June 27, 2008
Start Date ^ICMJE	March 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: May 2, 2007)	To obtain long-term safety and efficacy of Belatacept, in subjects who underwent a renal transplant, until Belatacept is marketed in the individual countires where the subjects are enrolled. [ Time Frame: Data will be reviewed on a yearly basis ]
Original Primary Outcome Measures ^ICMJE (submitted: September 9, 2005)	To obtain long-term safety and efficacy of Belatacept, in subjects who underwent a renal transplant, until Belatacept is marketed in the individual countires where the subjects are enrolled. Data will be reviewed on a yearly basis
Change History	Complete list of historical versions of study NCT00035555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 2, 2007)	To compare safety, efficacy and tolerability of Belatacept, as compared to cyclosporin. [ Time Frame: Data will be reveiwed on a yearly basis. ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 9, 2005)	To compare safety, efficacy and tolerability of Belatacept, as compared to cyclosporin. Data will be reveiwed on a yearly basis.

Descriptive Information
Brief Title ^ICMJE	Study Comparing the Safety and Efficacy of BMS-224818 to Cyclosporine, in Patients Receiving a Kidney Transplant, When Used in Combination With CellCept, Simulect, and Corticosteroids.
Official Title ^ICMJE	Phase II/III, Open-Label, Randomized, Controlled, Multiple-Dose Study of Efficacy and Safety of BMS-224818 as Part of a Quadruple Drug Regimen in First Renal Transplant Recipients
Brief Summary	The purpose of this study is to see if BMS-224818 treatment will be as efficacious as cyclosporine at preventing acute rejection, and a superior safety / tolerability profile (better kidney function, better blood pressure, less lipid problems, less diabetes mellitus, etc.)
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Graft Rejection Kidney Transplantation Renal Transplantation
Intervention ^ICMJE	Drug: LEA29Y, Belatacept
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	400
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion criteria Kidney transplant recipient Exclusion criteria HLA-identical living-related donor/recipient pairs active viral or bacterial infection multiple organ transplant recipients certain underlying causes of kidney failure
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00035555
Responsible Party
Study ID Numbers ^ICMJE	IM103-100
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP